# DEN140019: T2CANDIDA and T2DX Instrument

- Pathway: De Novo (Direct)
- Applicant: T2biosystems, Inc.
- Decided: Sep 22, 2014 after 118 days
- Product code: PII (Candida Species Nucleic Acid Detection System)
- Device class: 2
- Regulation: 21 CFR 866.3960
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K172708: T2Bacteria Panel (2018), 1 descendant of its own
- K173536: T2Candida 1.1 Panel (2017), 1 descendant of its own
- K234063: T2Candida 1.1 Panel (2024), 0 descendants of its own
- K233184: T2Bacteria® Panel (2024), 0 descendants of its own

## Indications for use
The T2Candida Panel and T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assay for the direct detection of Candida species in EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida Panel identifies five species of Candida and categorizes them into the following three species groups: 1. Candida albicans and/or Candida tropicalis, 2. Candida parapsilosis 3. Candida glabrata and/or Candida krusei The T2Candida Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida Panel does not distinguish between C. glabrata and C. krusei. The T2Candida Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification. The T2Candida positive and negative External Controls are intended to be used as quality control samples with the T2Candida Panel when run on the T2Dx® instrument system. These controls are not intended for use with other assays or systems.

Source page: https://510kreport.com/device/DEN140019
Methodology: https://510kreport.com/methodology